FMEA-menetelmän tuloksena saatiin tunnistetuille riskeille rikiprioriteettinumero, joka määriteltiin todennäköisyyden, vakavuuden ja havaittavuuden tulona. Saadut arvot eivät olleet absoluuttisia, vaan riskiarvioryhmän heille saatavissa olevan tiedon perusteella tekemä arvio olemassa olevista riskeistä. Riskiprioriteettinumero mahdollisti riskien luokittelun niiden kriittisyyden suhteen.Cross-contamination refers to the contamination of a raw material, product or other material by another substance or product. When different medicinal products are produced in shared facilities and equipment, the potential for cross-contamination becomes a significant issue for concern. Active substances provide a medicinal benefit to the intended patient; however as a cross over contaminant, they may affect to the quality of the product and even pose a risk to the patient.

The purpose of this thesis was provide and carry out a process that allows to assess risks and determine where control strategies are necessary to meet acceptable limits for cross-contamination. The aim of the process was to assure and document that the risk of cross-contamination is maintained at or below acceptable levels when processing multiple products in one facility.

Accordance with the principles described in the literature part, a cross-contamination risk assessment process was planned and carried out to one of the manufacturing department of Orion Oyj. Prior to commencing the risk assessment the risk assessment criteria and risk ranking system was defined and agreed. The risk ranking was based on the assessment of risk probability of occurrence, severity and detectability on a five-step scale.

The manufacturing department under assessment was divided into eight sub-areas on the basis of its structural boundaries. The activities in each sub-area were analysed and documented using the Failure Mode Effect Analysis (FMEA). The cross-contamination risk assessment considered four potential pathways for cross-contamination; the risk of mix-up, the risk of retention, the risk of mechanical transfer and the risk of airborne transfer.

The FMEA generated a risk priority number (RPN) based on the scores assigned for probability, severity and detectability. The score determined in the risk assessment was not an absolute value. Instead, it was the risk assessment working group’s evaluation of the existing risk, formed on the basis of information available to the group. The risk priority number enabled the assessed risks to be ranked in terms of priority.